Class 2 Device Recall Next Gen EMG Endotracheal Tube

• Date Initiated by Firm: December 22, 2021
• Create Date: March 10, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0743-2022
• Recall Event ID: 89280
• 510(K)Number: K112686
• Product Classification: Stimulator, nerve - Product Code ETN
• Product: NIM TRIVANTAGE EMG Endotracheal Tube
• Code Information: Products: 1) Product Number 8229705 (GTIN 00763000033934); Lots: 0218762694, 0218663943, 0219904500, 0220293429, 0220584798, 0220756285, 0220774358, 0221736070, 0221805033, 0222186741, 0222495993, 0222591367 2) Product Number 8229706 (GTIN 00763000033941); Lots: 0218663944, 0218664146, 0218762695, 0218762699, 0218762698, 0218762697, 0219010138, 0219010139, 0219010142, 0219010140, 0219010141, 0219278186, 0219272545, 0219278189, 0219278188, 0219278190, 0219444156, 0219444157, 0219278187, 0219444160, 0219444158, 0219444159, 0219444161, 0219836614, 0219972527, 0219969085, 0219972526, 0219972528, 0219836616, 0220087597, 0220087596, 0220087598, 0220293430, 0220293432, 0220293434, 0220293431, 0220293433, 0220293435, 0220371534, 0220371535, 0220371537, 0220371536, 0220517619, 0220517618, 0220584803, 0220584804, 0220734720, 0220769468, 0220769470, 0220878556, 0220769469, 0220878557, 0220934885, 0221123594, 0221123639, 0221248868, 0221248867, 0221248869, 0221493241, 0221543453, 0221543452, 0221637121, 0221637122, 0221710524, 0221805030, 0221805031, 0221805039, 0221805041, 0222048142, 0222024594, 0222057391, 0222140123, 0222200982, 0222200983, 0222200984, 0222239875, 0222239874, 0222352848, 0222396630, 0222428754, 0222465659, 0222495994, 0222495995, 0222495996, 0222542347, 0222542348, 0222563000, 0222563288, 0222738659, 0222719941, 0222684388 3) Product Number 8229707 (GTIN 00763000033958); Lots: 0218664151, 0218664148, 0218664149, 0218664157, 0218664156, 0218664155, 0218664150, 0218664154, 0218664158, 0218664153, 0218664152, 0218762700, 0218762705, 0218762701, 0218762704, 0218762703, 0218762806, 0218762702, 0218762807, 0218762812, 0218762809, 0218762814, 0218762815, 0219010143, 0219010144, 0219010145, 0219010806, 0219010807, 0219010809, 0219010813, 0219010811, 0219010810, 0219010808, 0219010812, 0219010814, 0219010816, 0219010818, 0219010819, 0219010817, 0219010820, 0219010815, 0219010821, 0219010822, 0219278191, 0219444374, 0219444375, 0219444376, 0219278193, 0219278196, 0219278195, 0219278192, 0219278197, 0219278194, 0219444369, 0219444370, 0219278198, 0219444371, 0219952959, 0219444372, 0219985176, 0219444373, 0219985177, 0219723502, 0219952958, 0220033883, 0220033885, 0220037915, 0220047459, 0220047460, 0220057008, 0220057009, 0220057010, 0220057011, 0220076607, 0220081032, 0220081037, 0220008824, 0220008823, 0220010546, 0220010547, 0220008825, 0220010548, 0220087591, 0220087602, 0220087599, 0220087601, 0220087600, 0220087603, 0220142052, 0220087886, 0220142053, 0220142054, 0220142055, 0220142060, 0220149776, 0220149778, 0220230467, 0220230468, 0220230472, 0220230469, 0220142057, 0220142058, 0220142059, 0220149779, 0220142063, 0220142064, 0220142062, 0220142065, 0220370784, 0220370785, 0220371526, 0220371528, 0220371527, 0220371530, 0220371529, 0220371531, 0220371532, 0220371533, 0220517189, 0220517190, 0220517620, 0220517621, 0220517191, 0220517193, 0220517194, 0220517192, 0220517195, 0220517196, 0220517197, 0220517199, 0220517200, 0220517198, 0220517201, 0220517202, 0220622252, 0220622253, 0220637407, 0220637408, 0220637409, 0220637410, 0220688264, 0220688265, 0220691509, 0220691510, 0220734718, 0220756281, 0220756282, 0220756283, 0220756284, 0220769471, 0220804919, 0220769472, 0220798476, 0220813969, 0220813970, 0220817687, 0220817686, 0220826216, 0220826217, 0220845825, 0220846126, 0220857889, 0220878558, 0220878559, 0220878561, 0220878560, 0220878562, 0220878563, 0220913062, 0220935486, 0220935487, 0220935488, 0220935489, 0220974382, 0221040035, 0221056071, 0221040036, 0221056072, 0221082044, 0221069155, 0221082126, 0221073627, 0221090328, 0221090327, 0221097604, 0221097605, 0221098067, 0221098066, 0221118571, 0221118572, 0221123591, 0221123638, 0221146333, 0221146457, 0221146458, 0221146460, 0221146459, 0221146461, 0221146462, 0221146463, 0221146879, 0221146889, 0221146901, 0221248875, 0221248876, 0221248877, 0221248878, 0221248879, 0221248880, 0221248881, 0221248882, 0221248883, 0221248884, 0221248885, 0221378722, 0221378724, 0221378725, 0221379386, 0221379387, 0221379388, 0221493665, 0221493866, 0221514981, 0221526915, 0221526917, 0221526918, 0221526920, 0221526919, 0221571421, 0221599118, 0221599117, 0221599181, 0221599119, 0221651974, 0221637118, 0221656119, 0221656118, 0221659143, 0221659144, 0221736003, 0221736005, 0221766209, 0221766208, 0221766211, 0221736786, 0221805043, 0221772984, 0221886337, 0221805044, 0221893434, 0221893435, 0221897719, 0221897720, 0221893433, 0221924396, 0221931540, 0221938902, 0221938901, 0221962166, 0221967955, 0222057392, 0222024589, 0222069694, 0222093329, 0222069692, 0222069693, 0222093330, 0222101075, 0222110921, 0222110922, 0222136940, 0222106107, 0222139599, 0222139600, 0222140118, 0222140119, 0222140125, 0222140446, 0222163047, 0222140120, 0222168488, 0222168489, 0222168491, 0222168492, 0222168493, 0222202227, 0222202226, 0222202228, 0222202230, 0222202231, 0222239881, 0222202232, 0222239878, 0222239882, 0222239883, 0222239884, 0222240046, 0222240047, 0222239885, 0222202229, 0222312293, 0222312878, 0222334222, 0222334223, 0222334220, 0222334221, 0222358414, 0222334224, 0222358415, 0222358416, 0222358417, 0222358418, 0222396631, 0222396632, 0222396634, 0222396633, 0222396635, 0222456848, 0222456849, 0222456850, 0222456851, 0222456852, 0222476127, 0222476128, 0222476130, 0222476131, 0222476129, 0222495997, 0222495998, 0222495999, 0222496000, 0222496001, 0222496002, 0222496003, 0222542350, 0222542349, 0222542352, 0222542351, 0222542353, 0222563004, 0222563286, 0222684391, 0222684395, 0222684394, 0222738663, 0222738660, 0222738661, 0222563287, 0222719938, 0222719943, 0222720028, 0222719945, 0222563002, 0222684393, 0222738665, 0222738664, 0222720029, 0222684392, 0222563001, 0222563005, 0222857893, 0222563003, 0222857891, 0222857894, 0222857892, 0222857896, 0222857895, 0222857897, 0222857898, 0222857900, 0222738662, 0222719944 4) Product Number 8229708 (GTIN 00763000033965); Lots: 0218664160, 0218664159, 0218664163, 0218664161, 0218664162, 0218762816, 0218762821, 0218762820, 0218762818, 0218762819, 0218762822, 0219278200, 0219278201, 0219278199, 0219278202, 0219444162, 0219444163, 0219444165, 0219444164, 0220087592, 0220087593, 0220087594, 0220087595, 0220142108, 0220142106, 0220142109, 0220293438, 0220293439, 0220228325, 0220142110, 0220293440, 0220517617, 0220517616, 0220658898, 0220517614, 0220517615, 0220370781, 0220142111, 0220730554, 0220370782, 0220370783, 0220855164, 0220855449, 0220855447, 0220873204, 0220855448, 0220935503, 0220935651, 0220935648, 0220935505, 0220935654, 0221056080, 0221056081, 0221097602, 0221097603, 0221146446, 0221146343, 0221146448, 0221146951, 0221146936, 0221248874, 0221378720, 0221588082, 0221588083, 0221637123, 0221710525, 0221710926, 0221851581, 0221851580, 0221893436, 0221931647, 0221931648, 0222031317, 0222081991, 0222101073, 0222140122, 0222140121, 0222217071, 0222240048, 0222302776, 0222358419, 0222358421, 0222396636, 0222396637, 0222456853, 0222456854, 0222476133, 0222542354, 0222563290, 0222720030, 0222739006 5) Product Number 8229709 (GTIN 00763000033972); Lots: 0222248291, 0218452814, 0218540733, 0218540734, 0218540735, 0218452815, 0218515807, 0218275886, 0218275305, 0218496850, 0219906760, 0220586086, 0220973095, 0221248873, 0221517237, 0221805028, 0222187092, 0222336506 6) Product Number 8229735 (GTIN 20763000041506); Lots: 0218275302, 0220584797, 0220883592, 0221996821, 0222146974 7) Product Number 8229736 (GTIN 20763000041513); Lots: 0221246105, 0218762830, 0218762829, 0219010518, 0219010517, 0219010516, 0219904499, 0219985174, 0220293436, 0220293437, 0220584799, 0220880266, 0220998690, 0221038763, 0221248866, 0221378719, 0221543451, 0221805267, 0222024592, 0222140124, 0222240053, 0222527962, 0222684399 8) Product Number 8229737 (GTIN 20763000041520); Lots: 0222908102, 0218762831, 0218762833, 0218762832, 0218762835, 0218762834, 0219010519, 0219733959, 0219744709, 0219788607, 0219785665, 0219795301, 0219788608, 0219795296, 0219795302, 0219795303, 0219802959, 0219802960, 0219836612, 0219836613, 0219904496, 0219904497, 0219972534, 0219972535, 0219972536, 0219972537, 0219985178, 0219972538, 0219802958, 0220010550, 0220010551, 0220010554, 0220010552, 0220010555, 0220087604, 0220087605, 0220142112, 0220142116, 0220142113, 0220142114, 0220230480, 0220228945, 0220230481, 0220230426, 0220230427, 0220230428, 0220230429, 0220230430, 0220293443, 0220293444, 0220293442, 0220713083, 0220734719, 0220734721, 0220769475, 0220769474, 0220769476, 0220785122, 0220790899, 0220826214, 0220847263, 0220826215, 0220857890, 0221010990, 0220998691, 0221034442, 0221035008, 0221038764, 0221056079, 0221248870, 0221248871, 0221248872, 0221378718, 0221463272, 0221463273, 0221493867, 0221493869, 0221493238, 0221493240, 0221543449, 0221637119, 0221637120, 0221718467, 0221766210, 0221805034, 0221805035, 0221805037, 0221805038, 0221924395, 0221910040, 0221967715, 0221931646, 0222024596, 0222024590, 0222024595, 0222034111, 0222034109, 0222065770, 0222119577, 0222123196, 0222187098, 0222334225, 0222358420, 0222396638, 0222456855, 0222496004, 0222496005, 0222739007, 0222563291, 0222684396, 0222719939, 0222720026, 0222739008, 0222562999, 0222542355, 0010791039 9) Product Number 8229738 (GTIN 20763000041537); Lots: 0218762837, 0218762838, 0218762840, 0218762842, 0218762841, 0219011550, 0219011551, 0219011552, 0219861141, 0219878783, 0219861136, 0219878782, 0219878784, 0219879026, 0219952951, 0219952952, 0220142117, 0220142118, 0220142119, 0220142120, 0220142121, 0220855453, 0220966544, 0221038762, 0221146339, 0221247365, 0221463276, 0221514982, 0221543448, 0221765700, 0221898348, 0222007804, 0222031318, 0222187101, 0222476134, 0222739009, 0222542356, 0222684398 10) Product Number 8229739 (GTIN 20763000041544); Lots: 0218762824, 0220584805, 0222024591, 0222272928, 0222476135
• Recalling Firm/ Manufacturer: Medtronic Xomed, Inc.; 6743 Southpoint Dr N; Jacksonville FL 32216-6218
• For Additional Information Contact: Brett Cromwell; 904-296-9600
• Manufacturer Reason for Recall: There is potential for multiple issues due to a manufacturing nonconformity.
• FDA Determined Cause: Process control
• Action: Medtronic will distribute a removal notice to impacted U.S. consignees, on 22-Dec-2021. A second attempt to notify US consignees is scheduled for the week of 02-Feb-2022. A third attempt to notify US consignees is scheduled for the week of 16-Mar-2022. Consignees are asked to take the following actions immediately: 1) Do NOT use any impacted product. Remove and quarantine all unused impacted product(s) in your inventory. 2) Return the impacted product(s) to Medtronic. Your Medtronic representative can assist in facilitating the return of the product as necessary. If an alternative product is needed, your Medtronic representative can assist you with identifying a suitable replacement product. 3) Complete the attached Customer Confirmation Form, and fax it to Medtronic at 800-897-3899 or 651-367-0814 to the attention of the FCA Execution Team or email it to neuro.quality@medtronic.com Consignees are asked to share the communication within their organization and with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action.
• Quantity in Commerce: 301,926 devices
• Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Faroe Islands, Finland, France, French Guinea, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea (Republic of), Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mauritius, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Panama, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = ETN and Original Applicant = MEDTRONIC XOMED, INC.